NCT05230901View on ClinicalTrials.gov

Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 23, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

March 31, 2026

Conditions
Aortic Stenosis, Severe
Interventions
OTHER

Standard of Care

Patients with CMR-derived ECV% levels ≥25.9% will be treated with standard of care according to current guidelines (Control group).

DRUG

Spironolactone 25mg

"Patients with CMR-derived ECV% levels ≥25.9% in Arm Spironolactone will receive spironolactone 25 mg/d in addition to standard of care medication ."

DRUG

Dihydralazine

"Patients with CMR-derived ECV% levels ≥25.9% in arm Spironolactone + Dihydralazine will receive spironolactone 25 mg/d + dihydralazine (2x12.5 mg/d p.o. in slow acethylators, and 2x25mg/d p.o. in fast acethylators, confirmed by genetic testing)"

Trial Locations (1)

37075

RECRUITING

University Medical Center Göttingen, Göttingen

All Listed Sponsors
lead

University Medical Center Goettingen

OTHER